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8:30 AM

Analytical Method Development, Validation and Transfer

Maritim ProArte Hotel Berlin, Germany, Friedrichstra├če 151, 10117, Berlin, Germany

The main objective of the conference is to facilitate industry benchmarking, practical discussions and regulatory agency feedback to enable faster and more effective analytical method development, validation and transfer.Speaker Faculty:Simeon Gill, Pharmaceutical Assessor, MHRA, UKAnders Karlsson, Associate Director, Analytical Science, Pharmaceutical Development, AstraZeneca R&D Mölndal, SwedenAnnick Gervais, Director, Physico-Chemical Method Development, Analytical Sciences for Biologicals, UCB, BelgiumAnnette Lauridsen, Associate Director, Analytical Technology, Biogen Idec,...


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8:50 AM

Genotoxic Impurities

Radisson Blu Hotel Berlin, Karl-Liebknech Strase 3DE-10178, Berlin, Germany

Guidance updates, regulatory insight and industry benchmarking for mutagenic impurity evaluation under ICH M72014 Conference highlights...Hear the latest on the finalisation of ICH M7 from members of the expert working group only 2 weeks after the final ICH meetingRare benchmarking opportunities: Gauge your company’s genotoxic impurities assessment strategies against those of Baxter, Roche, Janssen and Merck SeronoUnderstand the implications and practical challenges represented by the requirements of a 2nd in silico tool under the ICH M7 guidanceLearn how companies from across industry...

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